FDA 510(k)

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

K-Number: K203129 · 2021-01-12

Decision Date2021-01-12

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203129. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Precision Spine, Inc.. The 510(k) number is K203129.

When did NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System receive FDA 510(k) clearance?

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203129.

Who is the listed applicant for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

The FDA 510(k) record lists Precision Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System?

The FDA product code for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is OVE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT04388332ACDF Using Structural Allograft vs. Tritanium CRECRUITING NCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITING NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITING NCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

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Related Devices (Code: OVE)

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.